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FDA 510(k)

LED Eye mask (EY-20R, A20, EY-20N)

K-Number: K233556 · 2024-01-04

ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.
Decision Date2024-01-04
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Eye mask (EY-20R, A20, EY-20N) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-01-04 under 510(k) number K233556. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LED Eye mask (EY-20R, A20, EY-20N)?

LED Eye mask (EY-20R, A20, EY-20N) is a medical device that received FDA 510(k) clearance on 2024-01-04. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K233556.

When did LED Eye mask (EY-20R, A20, EY-20N) receive FDA 510(k) clearance?

LED Eye mask (EY-20R, A20, EY-20N) received FDA 510(k) clearance on 2024-01-04, under 510(k) number K233556.

Who is the listed applicant for LED Eye mask (EY-20R, A20, EY-20N)?

The FDA 510(k) record lists Shenzhen Kaiyan Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Eye mask (EY-20R, A20, EY-20N)?

The FDA product code for LED Eye mask (EY-20R, A20, EY-20N) is OHS.

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Related Devices (Code: OHS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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